Acceptability Study on Nutricomp® Drink Plus Fibre in Adults

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03013803

Acronym

Fuchsia

Enrollment

Registered

2017-01-09

Start date

2016-12-31

Completion date

2016-12-31

Last updated

2017-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Patients in Need of High-energy Oral Nutritional Supplementation

Brief summary

Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus Fibre to show that it is acceptable for patients in the United Kingdom.

Interventions

DIETARY_SUPPLEMENTNutricomp Drink Plus Fibre

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male and female participants ≥ 18 years of age * Assessed to have malnutrition or be at risk of malnutrition by a Dietician within the investigator team. Assessment to include, but not limited to weight loss history, current BMI/MUST score, anamnesis, dietary intake history and predicted future oral intake. * Anticipated period of nutritional support ≥ 12 days * Patient has the capacity and is willing to provide informed consent.

Exclusion criteria

* Participants with mental in capabilities who are unable to give informed consent * Hypersensitivity to any of the active substances or excipients within the IP * Severely impaired gastrointestinal function or complete failure * More than 50% of nutrition from Parenteral Nutrition * Simultaneous participation in another interventional study * Participants who are unwilling or mentally and/or physically unable to adhere to study procedures * Participants with dysphagia requiring thickened fluids * Participants with significant renal impairment (CKD) * Pregnancy

Design outcomes

Primary

Measure	Time frame
Occurrence of gastrointestinal tolerance parameters	Day 1 - day 13

Secondary

Measure	Time frame
Occurrence of (further) adverse events during the treatment period (yes/no, if yes timing/duration/assumed cause/seriousness/severity)	Day 1 - day 13
Palatability evaluation performed under controlled condition using a questionnaire with a 5 point hedonic scale rang	Day 1 - day 13

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026